{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "31968",
      "product_res_number": "Z-0770-04",
      "event_date_initiated": "2004-02-23",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-09-15",
      "res_event_number": "28473",
      "product_code": "MHI",
      "k_numbers": [
        "K983399"
      ],
      "product_description": "Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits.\n\nThese are sold under two names as follows:\nMeridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay",
      "code_info": "Lots 081077, 081093, 081138, 071093, 071138.",
      "firm_fei_number": "1000520007",
      "recalling_firm": "Genzyme Diagnostics",
      "address_1": "6659 Top Gun St",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4113",
      "additional_info_contact": "Gene Goorchenko\n858-777-2614",
      "reason_for_recall": "False Positive results.",
      "root_cause_description": "Other",
      "action": "Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.",
      "product_quantity": "2671 kits",
      "distribution_pattern": "Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.",
      "openfda": {
        "k_number": [
          "K952467",
          "K955897",
          "K982245",
          "K922675",
          "K911337",
          "K912408",
          "K942098",
          "K031942",
          "K963135",
          "K922010",
          "K931147",
          "K955157",
          "K020583",
          "K103673",
          "K024113",
          "K920817",
          "K944871",
          "K915093",
          "K120001",
          "K930451",
          "K912152",
          "K081064",
          "K983399",
          "K031834",
          "K033274",
          "K953284",
          "K982711"
        ],
        "registration_number": [
          "3003750284",
          "3022178699",
          "1122855",
          "3024463179",
          "2030538",
          "3017772438",
          "3004569406",
          "2032839",
          "8010096",
          "3005360469",
          "3002800697",
          "3009935129",
          "2013736",
          "1924669",
          "1524213",
          "2031468",
          "2029372",
          "2245285"
        ],
        "fei_number": [
          "3003750284",
          "3002023342",
          "3022178699",
          "3006224287",
          "3024463179",
          "1000306617",
          "3017772438",
          "3004569406",
          "3004185580",
          "1000520007",
          "3002800697",
          "1924669",
          "3009935129",
          "2013736",
          "3005670738",
          "1524213",
          "1000123404",
          "2245285"
        ],
        "device_name": "Giardia Spp.",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3220",
        "device_class": "2"
      }
    }
  ]
}